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Table 2 Primary and secondary outcome measures

From: Epicardial delivery of autologous atrial appendage micrografts during coronary artery bypass surgery—safety and feasibility study

Primary outcome measures Secondary outcome measures
Safety Preliminary efficacy
 For assessing hemodynamics during the operation and at the intensive care unit  For assessing cardiac function and remodeling as measured by MRI
  1. Need for vasoactive medication   1. Left ventricular wall thickness
  2. Cardiac index in l/min/m2   2. Change in the amount of myocardial scar tissue
  3. Hemoglobin in g/l   3. Change in left ventricular ejection fraction
  4. Oxygen saturation in the pulmonary arterial blood (SvO2) in %   4. Change in movement and diastolic function of left ventricular wall
  5. Serum potassium level in mmol/l  Others
  6. Blood glucose level in mmol/l   1. Plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels
 For assessing cardiac function during and after the operation by echocardiogram   2. New York Heart Association class
  7. Left ventricular ejection fraction (EF) in %   3. Days in hospital
  8. Pericardial effusion in mm   4. Changes in the quality of life measured by questionnaire
 For assessing cardiac function after the operation  
  9. Telemetric monitoring of rhythm  
 Feasibility  
  1. Success in completing the delivery of the transplant to the myocardium  
  2. Waiting time in minutes for the finished transplant to be placed on the myocardium after doing all the required anastomoses  
  3. Waiting time in minutes for the heart after doing all the anastomoses and before the transplant is finished  
  4. Closing the right atrial appendage after removing the standardized tissue piece for preparing the transplant